|As much as the AmeriKat adores|
administrative AIPPI issues, a much needed
bubble bath was required in preparation for
the Gala Dinner
"The plenary session on Q238: “Second medical use and other second indication claims” was chaired by Ian Karet (Linklaters, UK), who used humour and diplomacy to maintain authority over the AIPPI troops in attendance.
Claire Baldock (Boult Wade Tennant, UK) introduced the session by outlining the tremendous patient benefit that can be achieved from incremental innovation such as a second medical use discovery. Second medical use drugs have the added benefit that their toxicology profile is likely to have already been assessed for previous indications, and much more will be known about the drug than new compounds. Despite these benefits, significant enforcement challenges remain, and it can difficult to determine when a second medical use claim has been infringed.
Sarah Matheson (Allens, Australia) gave an overview of the 43 national reports that were submitted on Q238. These reports are available on the AIPPI website. The national reports formed the basis for the proposed resolution.
Around 85% of reports confirmed that some form of second medical use claims were permitted. There was more controversy as regards the permissibility of certain types of claim, such as new dosage regimes, or a patient class. Most jurisdictions reported some limitation on the form of claims allowed, with 75% allowing EPC 2000 style purpose limited product claims, in comparison with only 35% for Swiss form claims.
In relation to identifying the particular parties who might be liable for infringement of a full label product that explicitly covers a patented second medical use, 100% of jurisdictions reported that the drug manufacturer would be liable. By way of comparison, 80% of jurisdictions were of the view that dispensing pharmacists would be liable, 45% of jurisdictions thought that the prescribing physician would be liable and 12.5% of jurisdictions were of the opinion that the patient would be liable. However, Matheson noted that there were significant grey areas in these responses, and many jurisdictions did not have case law on these specific issues. 95% of responses agreed that harmonisation was desirable, and many emphasized the need for the regulatory framework and patent law to operate together. Another key theme included uncertainty regarding enforcement by patentees in relation to skinny label products, with a carve out for the patented indication.
Andri Hess (Homburger, Switzerland) who chaired the working committee explained that every resolution had passed in the working committee with very high majorities. The resolution is broadly composed of three parts: (1) patent eligible subject matter; (2) infringement; and (3) regulatory issues.
Several amendments were proposed in the plenary session, including a request from the French delegation to delete paragraph 12 which provides that "injunctive relief for infringement of a patented second medical use should not be denied solely because such relief could prevent a pharmaceutical from being commercialised for non-patented uses. Consideration should be given to all the circumstances of the case, including the interests of the involved parties”. The concern was that the resolution did not give Courts sufficient discretion to refuse an injunction. However, the proposed amendment was rejected, suggesting that the wording was sufficiently flexible to refuse an injunction if that was appropriate on the facts of a particular case.
The final resolution on Q238 was adopted at the Executive Committee session on Wednesday afternoon, with 185 votes in favour, 4 against, and 4 abstentions.
This writer wonders whether the final resolution will be used by international or national AIPPI groups to bring these issues to the attention of the relevant authorities and, as a consequence, whether the authorities will take any action."